DEVICE: GUM® (00070942007849)

Device Identifier (DI) Information

GUM®
KIT59
In Commercial Distribution

SUNSTAR AMERICAS, INC.
00070942007849
GS1

1
025066358 *Terms of Use
US Professional Dental Sample Kit comprised of 1 x 525PHS Deep Clean Technique Toothbrush 1x 2030PQA Expanding Floss 1 x 828PQ Twisted Mint Flosser 1 x 872PQ Proxabrush Tight Interdental Brush 1 x 3612PQ Proxabrush Moderate Interdental Brush 1 x 650PA Soft Pick Advanced Interdental Pick 1 x 308PD End Tuft Toothbrush 1 x 600PYC Rubber Tip Stimulator 1 x 760PB Tongue Cleaner /Scraper 1 x 895 PQ Crayola Kids Flosser 1 x 227A Crayola Marker Toothbrush
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
No
No
Yes
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
33208 Periodontal pick/brush, reusable
A manual, pointed, oral hygiene device with a soft tip or bristles intended to be used to stimulate and massage the gums to promote good periodontal (gum) condition, and to clean and remove plaque and debris from between the teeth and gingival surfaces. It may also be referred to as an interdental/interproximal brush and is intended for use in the home. This is a reusable device.
Active false
31817 Basic manual toothbrush
An instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. This is a reusable device.
Active false
11158 Dental floss
A string-like device formed as thread or tape, used for the removal of plaque and/or debris from the proximal surfaces of teeth and the gingival surfaces of fixed prostheses. It is typically made of a synthetic fibre. After application, this device cannot be reused.
Active false
42538 Tongue scraper, reusable
A device used to scrape the upper surface of the tongue to promote oral hygiene (e.g., to remove plaque, food debris, and bacteria, and to prevent bad breath). It is normally available [non-prescription] over-the-counter (OTC). It is typically made of copper (Cu) because of its biostatic properties (i.e., bacteria will not grow on its surface), and has a scraping ridge that is manually pulled over the surface of the tongue. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JES Floss, Dental
EFW Toothbrush, Manual
JET Pick, Massaging
LCN Scraper, Tongue
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

ddaae650-a939-4e38-8050-887fe26c4ac8
November 07, 2024
1
October 30, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
No
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No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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